Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment.

Time frame: baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)

Population: All enrolled participants diagnosed with metastatic breast cancer, had measurable disease at baseline, and received at least one dose of study drug. Two participants were excluded from analysis because they received chemotherapy for locally advanced/metastatic breast cancer within 6 months prior to enrollment.

Measured from the time of first documentation of complete response (CR) or partial response (PR), whichever status is first recorded, until the date of objective disease progression or death on study, whichever occurs first, with censoring defined in the same way as for progression-free survival.

Time frame: time of response to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)

Population: Enrolled participants who were considered responders (had either a complete response or partial response).

Original outcome was overall survival = time from date of enrollment to date of death due to any cause. Survival time was censored at date of last contact for participants who were still alive or lost to follow-up. Because only 8 participants had documented death while on study, results are reported as 6- and 12-month overall survival probability.

Time frame: baseline to date of death from any cause

Population: All enrolled participants. Fifty-two participants were censored.

Defined as the time from enrollment to the date of objective disease progression or death on study, whichever occurs first. Censoring was determined based on US-FDA 2005 draft guidance on clinical endpoints.

Time frame: baseline to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)

Population: All enrolled participants. Forty-two participants were censored.

Defined as time from enrollment to the date of death due to any cause, measured disease progression, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started.

Time frame: baseline to stopping treatment

Population: All enrolled participants. Time to treatment failure for participants who are still participating in the study without treatment failure at the time of analysis will be treated as censored at thte date of the last tumor assessment (3 participants censored).